Development and Pilot Testing of a Multimodal Web-based Program to Address Heavy Drinking During Smoking Cessation
1 other identifier
interventional
119
1 country
1
Brief Summary
The overall objective of this project is to develop and pilot-test a web-based smoking cessation program that specifically addresses heavy drinking (HD). The project builds upon a well-established, free evidence-based smoking cessation website, BecomeAnEX.org ("EX"), which is supported by Truth Initiative, a national non-profit public health organization, and its research arm, the Schroeder Institute. Investigators will develop an alternative version of BecomenAnEX that will include detailed content on alcohol's relation to smoking relapse, health effects of alcohol (including moderate drinking recommendations) along with related worksheets, feedback materials, and links to resources for drinking. Once a version of BecomeAnEX is developed that specifically addresses HD (called EX-HD), the investigators will conduct a one-arm open pilot of the site with 30 HD smokers recruited from newly registered BecomeAnEX users. The study will gather participant feedback on the site as well as site use metrics (e.g., number of logins, number of pages viewed, use of interactive components) and will revise EX-HD in response to this feedback in preparation for Stage 1b work. Stage 1b will use the updated EX-HD version to run a small scale randomized clinical trial where 120 participants will be randomly assigned to the standard version of BecomeAnEX or to EX-HD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedStudy Start
First participant enrolled
May 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedResults Posted
Study results publicly available
October 7, 2019
CompletedOctober 7, 2019
September 1, 2019
11 months
February 23, 2017
August 23, 2019
September 16, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month
Self-report abstinence from smoking
1 month after enrollment
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months
Self-report abstinence from smoking
6 months after enrollment
Number of Heavy Drinking Days at 1 Month
Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
1 month after enrollment
Number of Heavy Drinking Days at 6 Months
Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
6 months after enrollment
Study Arms (2)
Standard Web-based Smoking Cessation
ACTIVE COMPARATORA website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Alcohol-focused Web-Based Smoking Cessation
EXPERIMENTALA modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish.
Interventions
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Eligibility Criteria
You may qualify if:
- current daily smoking of at least one cigarette per day
- meeting NIAAA criteria for past month heavy or at-risk drinking (for women: drinking 8+ drinks per week or consuming 4+ drinks on one occasion at least once in the past month; for men: drinking 15+ drinks per week or consuming 5+ drinks on one occasion at least once in the past month)
- age 18 or older
- willingness to provide contact and mailing information following consent
You may not qualify if:
- \. history of severe alcohol withdrawal as indicated by past alcohol-induced seizures or delirium tremens;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
- Truth Initiativecollaborator
Study Sites (1)
Center for Alcohol and Addiction Studies, Brown University
Providence, Rhode Island, 02912, United States
Related Publications (1)
Kahler CW, Cohn AM, Costantino C, Toll BA, Spillane NS, Graham AL. A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial. JMIR Form Res. 2020 Jun 8;4(6):e7570. doi: 10.2196/formative.7570.
PMID: 32348286DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher Kahler
- Organization
- Brown University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 23, 2017
First Posted
March 3, 2017
Study Start
May 11, 2017
Primary Completion
April 1, 2018
Study Completion
April 30, 2018
Last Updated
October 7, 2019
Results First Posted
October 7, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share